Phase II Study of Bendamustine and fixed dose Nivolumab in Children and young adults with Relapsed or Refractory Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. To assess the safety and efficacy of the combination of bendamustine and fixed dose nivolumab among children and young adults with relapsed or refractory Hodgkin Lymphoma.
研究概览
简要总结
Hodgkin lymphoma, also known as Hodgkin disease, is a type of cancer that develops in the lymphatic system. Children and young adults with relapsed or refractory Hodgkin Lymphoma are difficult to treat. Previously the treatment used to be chemotherapy. Multiple studies have shown that chemotherapy is not very effective to cure the disease. New drugs which are based on the principle of immunotherapy are being studied. One such drug is Nivolumab which targets specific proteins on the cancer cells. Multiple studies have shown that Nivolumab when used alone or in combination with other chemotherapy drugs are effective for disease control and also have minimal side effects. In this study we want to learn the efficacy of Nivolumab and Bendamustine in causing remission in patients with relapsed or refractory Hodgkin lymphoma. This trial is conducted to answer two questions; 1) How effective is the drug combination of Nivolumab and Bendamustine in producing remission in relapsed and refractory Hodgkins lymphoma 2) What are the toxicities associated with this drug combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •All diagnosed cases of first or subsequent relapse and refractory Hodgkins Lymphoma proven by histopathology
- •Written informed consent according to institutional guidelines.
排除标准
- •Participants more than 25 years of age
- •Subjects with nodular lymphocyte-predominant HL
- •HL previously documented to be nonresponsive to nivolumab
- •Prior radiation therapy within 3 weeks, or chest radiation less than or equal to 24 weeks prior to first cycle of therapy
- •Seropositive for hepatitis B, hepatitis C, and HIV
- •History of or active autoimmune disease
- •Subjects with active interstitial pneumonitis
- •History of allergy to study drug components
- •Patients with renal, liver or cardiac compromise as determined by the clinician.
结局指标
主要结局
1. To assess the safety and efficacy of the combination of bendamustine and fixed dose nivolumab among children and young adults with relapsed or refractory Hodgkin Lymphoma.
时间窗: Toxicities during and after 3 cycles of nivolumab and bendamustine | PET-CT after 3rd cycle to assess Complete Metabolic Response (Deauville Score 1–3)
次要结局
- 1. To estimate the feasibility of High-Dose Chemotherapy/ Autologous Bone Marrow Transplant in patients with high-risk relapsed or refractory Hodgkin Lymphoma.(2. To estimate the feasibility and efficacy of delivering nivolumab maintenance among high-risk relapsed or refractory Hodgkin Lymphoma.)